Funder: California Institute for Regenerative Medicine
Due Dates (Anticipated): January 2027 (Application) | April 2027 (Application) | July 2027 (Application) | October 2027 (Mandatory consultation) | October 2027 (Application)
Funding Amounts: Up to $8 million–$15 million in total costs, depending on trial stage and applicant status, for up to four years
Summary: Supports completion of phase 1, 2, or 3 clinical trials of stem cell-based or genetic therapies addressing serious unmet medical needs.
Key Information: A Clinical Development team consultation is mandatory before submission, and every trial must include a California site.
Description
The California Institute for Regenerative Medicine (CIRM) supports completion of a single interventional phase 1, 2, or 3 clinical trial, including pivotal trials, under an FDA-cleared protocol. CLIN2 targets innovative stem cell-based and genetic therapies with potential to deliver transformative benefits to patients, families, and the healthcare system.
Projects should advance a comprehensive development strategy toward marketing approval, incorporate stage-appropriate patient access and commercialization planning, and enroll participants reflective of the disease population. Alongside clinical operations, awards support data sharing, patient support, and strategic planning. Associated natural history studies, healthy-volunteer lead-in studies, biomarker and potency assay development, and certain manufacturing activities may also be supported. CIRM contributes internal resources and external subject-matter expertise to help advance funded projects.
